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Yale Journal on Regulation




Important scientific discoveries in the field of human genetics have been reported in the nation's major newspapers since the beginning of the decade, and these discoveries have given rise to a multi-billion dollar industry. Mr. Malinowski and Professor O'Rourke explore the impact of federal policy on the field and the resulting industry. They argue that federal policy in support of genetics research and development has not been followed by the introduction of regulatory and health policy necessary for the efficient and responsible commercialization of the industiy's products. As a consequence, Mr. Malinowski and Professor O'Rourke suggest, federal policy may have given rise to a 'false start "for the industry. The authors suggest that, in light of the potential impact of genetics products on human health and the societal and ethical implications of said technologies, ignoring the policy and regulatory questions surrounding genetics products is, at best, irresponsible. Mr. Malinowski and Professor O'Rourke identify many of the regulatory shortcomings and offer a series of reforms and suggestions to foster the responsible commercialization of the forthcoming generation of genetics products.



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